Evaluate the Efficacy and Safety of CMG190303 in Patients With Type 2 Diabetes and Dyslipidemia

Screening (Visit 1) Inclusion Criteria 1. A male or female adult aged between 19 and 80 in South Korea 2. An individual with type II diabetes and dyslipidemia 3. An individual meeting any of the followings at the time of the screening 1. Metformin monotherapy: An individual who was on a stable dose of metformin ≥1,000 mg/day as monotherapy for at least 6 weeks prior to screening (for a patient who took a dyslipidemia treatment within 4 weeks from the screening, the patient had to be on a stable dose of metformin ≥1,000 mg/day as monotherapy for at least 2 weeks prior to the screening) 2. Dual combination therapy: An individual who was on a stable dose of metformin ≥1,000 mg/day for at least 1 week prior to the screening in combination with additional oral diabetes treatment (DPP-4i, TZD, SU) 4. An individual meeting the following criteria for HbA1c at the time of the screening 1. Metformin monotherapy: An individual with 7.0% ≤ HbA1c ≤ 10.5% whose blood sugar level is not adequately controlled 2. Dual combination therapy: An individual with 6.5% ≤ HbA1c ≤ 10% whose blood sugar level is not adequately controlled 5. An individual with FPG (Fasting Plasma Glucose) ≤ 270 mg/dL at the time of the screening 6. A patient who did not take a dyslipidemia treatment within 4 weeks from the screening and whose fasting serum lipid test level is 100 mg/dL ≤ LDL-C ≤ 250 mg/dL and TG ≤ 400 mg/dL 7. A patient who took a dyslipidemia treatment within 4 weeks from the screening and was on monotherapy of a statin-class drug as a dyslipidemia treatment for at least 6 weeks prior to the screening (an individual who took omega-3 alone or omega-3 in combination with a statin-class drug is considered to have taken the monotherapy of a statin drug as described here) 8. An individual who voluntarily consented to participating in the clinical study and signed the informed consent form Randomization (Visit 2) Inclusion Criteria 1. An individual who continuously took metformin ≥1,000 mg/day before the randomization (after the screening visit (Visit 1)) and underwent the wash-out period, TLC and run-in period as described below 1. An individual who took metformin monotherapy but did not take a dyslipidemia treatment: An individual who underwent the TLC for 2 weeks and the TLC and placebo run-in period at the same time for 2 weeks 2. An individual who took metformin monotherapy and took a dyslipidemia treatment: An individual who underwent the wash-out period for at least 4 weeks, the TLC for 2 weeks, and the TLC and placebo run-in period at the same time for 2 weeks 3. An individual who took a dual combination therapy of an oral diabetes treatment other than metformin and did not take a dyslipidemia treatment: An individual who underwent the wash-out period for at least 6 weeks, the TLC for 2 weeks, and the TLC and placebo run-in period at the same time for 2 weeks 4. An individual who took a dual combination therapy of an oral diabetes treatment other than metformin and took a dyslipidemia treatment: An individual who underwent the wash-out period for at least 6 weeks, the TLC for 2 weeks, and the TLC and placebo run-in period at the same time for 2 weeks 2. An individual with 7.0% ≤ HbA1c ≤ 10.5% based on the central laboratory test on a visit 1-4 (Run-in visit) 3. An individual with FPG (Fasting Plasma Glucose) ≤ 270 mg/dL based on the central laboratory test on a visit 1-4 (Run-in visit) 4. An individual whose fasting serum lipid test level is 100 mg/dL ≤ LDL-C ≤ 250 mg/dL and TG ≤ 400 mg/dL based on the central laboratory test on a visit 1-4 (Run-in visit) 5. An individual with medication compliance of 70% or higher during the run-in period Screening Visit (Visit 1) Exclusion Criteria 1. A patient with hypersensitivity to the active ingredient (dapagliflozin or rosuvastatin) or any component of the investigational product 2. A pregnant woman, a breastfeeding woman, or a woman of childbearing potential or a man who does not agree to use an appropriate contraceptive method\* during the clinical study \*: a. Implantation of an intrauterine device or intrauterine system, b. Dual barrier method for men or women of childbearing potential (condom and contraceptive vaginal diaphragm, vaginal sponge or cervical cap), c. Sterilization (vasectomy, bilateral tubal ligation, etc.) 3. A patient with the body mass index (BMI) \< 15 kg/m2 or \> 40 kg/m2 4. An individual with the following medical history or laboratory test abnormality 1. A patient with type I diabetes or secondary diabetes or severe diabetes complications 2. A patient with metabolic acidosis such as diabetic ketoacidosis 3. A patient with acute arterial disease at the time of screening (e.g., a patient with a medical history of unstable angina, myocardial infarction, transient ischemic attack, cerebrovascular disease, coronary artery bypass graft, or coronary intervention within 3 months prior to entry to the study) 4. A patient with a medical history of severe heart failure (NYHA class III to IV), severe heart valve disease, severe obstructive/hypertrophic myocardial disease, severe obstructive coronary artery disease, abdominal aneurysm, or uncontrolled arrhythmia, that occurred within 24 weeks prior to the screening 5. A patient with uncontrolled hypertension (systolic blood pressure ≥ 180 mmHg or diastolic blood pressure ≥ 110 mmHg) or hypotension (systolic blood pressure \< 90 mmHg or diastolic blood pressure \< 60 mmHg) 6. An individual with uncontrolled thyroid dysfunction (TSH (Thyroid Stimulating Hormone) ≥ 1.5 X ULN, or an inability to maintain a stable TSH level in the opinion of the investigator) 7. An individual with a medical history of myopathy, including rhabdomyolysis, or whose CK is 2 times or higher the upper limit of normal range of CK 8. A patient with severe renal impairment (eGFR \< 45 mL/min/1.73 m2 for a patient taking metformin at 1,000 mg, or eGFR \< 60 mL/min/1.73 m2 for a p…

Reproduced word-for-word from the public registry record — the study team can answer questions about it.